Asthma and COPD (chronic obstructive pulmonary disease) affect more than 44 million Americans. These chronic conditions require lifetime therapy. The mainstay of treatment today focuses on systemic medications, local (inhaler) therapies, oxygen therapy and mucous clearing devices. Methods of respiratory support as well as intrapulmonary percussive treatments have been employed for airway clearance and relief, but no devices or methods have been provided which are designed for delivering specific sequences of specific frequencies targeted to elicit beneficial effects in a patient according to the characteristics of the patient's illness as described herein.
To date the therapeutic impact of intrapulmonary percussive devices has not been significant enough for such technology to become standard care.
The device relates to means and methods of causing vibrations in the chest wall, amongst other effects. Some of the known effects of such vibrations are summarized below.
Koiwa et. al showed that vibrations over the chest wall at 50 Hz, that were phase controlled, i.e., activated from the onset of isovolumic relaxation to end-diastole, caused a relaxation of the left ventricle, which was significantly more pronounced in heart failure and cardiomyopathy patients than in healthy patients. [Modification of Human Left Ventricular Relaxation by Small-Amplitude, Phase-Controlled Mechanical Vibration on the Chest Wall. Yoshiro Koiwa, MD; Hideyuki Honda, MD; Takehiko Takagi, MD; Jun-ichi Kikuchi, MD; Nobuo Hoshi, MD; Tamotsu Takishima, MD. Circulation. 1997; 95:156-162.]
Takagi et. al further showed that improved relaxation of the left ventricle by applying phase-controlled vibrations accelerate the LV relaxation rate and that this increased relaxation improves systolic function through the Frank-Starling mechanism. [Diastolic vibration improves systolic function in cases of incomplete relaxation. T Takagi, Y Koiwa, J Kikuchi, H Honda, N Hoshi, J P Butler and T Takishima. Circulation. 1992; 86:1955-1964]
Nakayama et. al found that in-phase vibrations (IPV) applied over the chest of COPD patients reduced their mea arterial pulmonary pressure and pulmonary vascular resistance, while increasing their PaO2 and decreasing their PaCO2 significantly. They conclude that IPV improves gas exchange and pulmonary circulation without affecting systemic circulation. [Benefit of in-phase chest wall vibration on the pulmonary hemodynamics in patients with chronic obstructive pulmonary disease. Nakayama H, Shibuya M, Kaneko N, Yamada M, Suzuki H, Arakawa M, Homma I. Respirology. 1998 December; 3(4):235-40.]
Kun Jiao el al. studied the effect of vibrations on the heart rate variability and driving fatigue of healthy volunteers. They compared the effect of 1.8 Hz, 6 Hz and no vibrations at all, and found that different vibrations caused different levels of fatigue, as measured subjectively by a questionnaire; and that different frequencies also caused different effects on the autonomic nervous system, as measured heart rate variability changes. [Effect of different vibration frequencies on heart rate variability and driving fatigue in healthy drivers. Kun Jiao, Zengyong Li, Ming Chen, Chengtao Wang, Shaohua Qi. Int Arch Occup Environ Health (2004) 77: 205-212]
U.S. Patent Application No. 20080156319 ('319) to Avni discloses a pulsating inhaler comprising a fluid oscillator providing a focused fluid column with a series of alternating high and low pressure zones, a drug dispenser adapted for releasing small and constant measures of at least one drug via the fluid column, and, at least one outlet orifice adapted to direct the focused fluid column towards the respiratory tract of a patient. The small and constant measures of the drug are delivered to the patient's lungs while its respiratory tracts are gently and continuously vibrated. As acknowledged, applying a sequence of pneumatic pulses to the patient's airways through the oral cavity results in therapeutic effects.
However, '319 does not teach protocols comprising optimal parameters efficacious in treating disorders or for uptake of medicaments.
Congestive Heart Failure (CHF) and Pulmonary Oedema, both being conditions with a significant pulmonary component, are examples of other conditions which would benefit from an improvement in means and methods for treatment.
Providing means and methods of generating and delivering discrete wave trains of different repetition frequencies and pulse amplitudes which are efficacious in treating pulmonary, cardio-pulmonary and breathing disorders which are more effective long term, more easily supervised and fine—tuned would fulfill a long felt and unmet need.